Aclaris Therapeutics, Inc. announced positive results from a Phase IIb clinical trial of the Company’s lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing multiple seborrheic keratoses (SK). Though the lesions are benign, many patients elect to have SK treated, either because the lesions are irritated or are cosmetically concerning.

The double-blind, vehicle-controlled Phase IIb clinical trial was designed to evaluate the safety, tolerability, and efficacy of A-101 in removing multiple SK lesions on the trunk and extremities. The trial used a parallel-group design to compare two concentrations of A-101 and vehicle (placebo) in 172 subjects with SK lesions. Results from the study showed A-101 achieved statistical significance in clearing SK lesions in a dose-related fashion. A-101 was well tolerated at both concentrations studied.

“This positive outcome represents an important milestone for A-101 and further demonstrates its potential as a non-invasive treatment for SK, a condition for which there are currently no FDA-approved therapies”, said Dr. Neal Walker, President and CEO of Aclaris. “These findings, along with results from a second, ongoing Phase IIb study to evaluate A-101 in treating SK lesions on the face, will be used to support the progression of A-101 into Phase III trials. Results from the second Phase IIb study are expected later this quarter.”

Currently, SK lesions are treated using modalities such as cryosurgery, electrosurgery, curettage, or surgical removal which may be painful and may often result in pigmentary changes and/or scarring at the treatment site.

“These study results are promising and suggest that A-101 may have the potential to address an unmet medical need,” said Janet DuBois, MD, a dermatologist in Austin, TX and an investigator on multiple A-101 clinical trials. “While cryotherapy is the most commonly used treatment for the removal of SK lesions, it is painful for patients and sometimes results in permanent hypopigmentation. A well-tolerated, FDA-approved, non-invasive treatment option for SK would be a welcome advance for patients and physicians.”